Purpose The purpose of this Notice is to announce an interest in research addressing patients with emergency medical conditions, including trauma. Background Over 145 million people are seen in emergency departments across the US. Emergency departments are the source of twelve million admissions, or 35% of all hospital admissions and 14% of all outpatient visits. This includes over 27 million children under the age of 15, 23 million adults over the age of 65 and over 42 million visits for injuries and major trauma. When they learn of a patient's new symptoms, primary care providers often use the emergency department to obtain rapid diagnostic tests and a treatment plan. Emergency Departments are the only component of the country's healthcare system that is accessible at any time of the day or night, and by law they provide treatment regardless of the ability to pay. Rapid assessment and treatment within the first minutes or hours after the onset of illness plays a major role in determining both the trajectory of recovery and future healthcare costs. Research in the emergency setting offers a unique opportunity to improve not only the treatment of acute life-threatening disorders, but also a spectrum of common disorders that encompass a considerable burden of illness and account for a major component of health care costs.

The Lewy Body Dementias (LBD) are frequently misdiagnosed or underdiagnosed during life, and despite the development of diagnostic criteria at multiple expert consensus conferences, the gold standard for diagnosis remains post-mortem brain analysis. Improvement in diagnostic accuracy during life, and the development of good quality diagnostic biomarkers, would be greatly facilitated if comprehensive, longitudinal clinical and biological data obtained on patients during life were regularly linked with detailed post-mortem brain examination. In response to recommendations from the Alzheimer's Disease Related Dementias (ADRD) Summits convened by the NINDS in 2013, 2016, and 2019, longitudinal clinical data and biospecimens are being collected from patients with LBD and shared with the research community through the Parkinsons Disease Biomarker Program (PDBP). The PDBP is an NINDS-funded resource that collects standardized clinical data and biospecimens longitudinally on patients with Parkinson's Disease (PD) and PD-related disorders (including LBD) with the goal of accelerating the pace of biomarkers research. The PDBP currently has data and biospecimens on about 1900 subjects, some of whom have gone to autopsy, though relatively little post-mortem data on these subjects is available in PDBP at this time. This NOSI encourages researchers with extensive pre- and post-mortem data on patients with LBD to apply for supplemental funds to be used for the purpose of adding this data to the existing NINDSPDBP repository. Supplements may be requested by: Researchers who have previously contributed clinical and biospecimen data to the PDBP on patients with LBD while alive, and who wish to add the post-mortem autopsy data they have collected on the same patient(s) after their death.

Accumulation of abnormal proteins such as alpha-synuclein or tau in the brains of patients with dementia tends to occur in specific brain structures (cells/circuits/regions), resulting in the unique clinical presentations that are characteristic of the different types of dementia. This funding opportunity announcement invites applications that seek to identify mechanisms responsible for this selective regional vulnerability to abnormal protein deposition in the brains of patients with Lewy Body Dementia or Frontotemporal Dementia.

Notice Special Interest NOSI): Platform Trials Thrombectomy Acute Stroke Treatment Notice Number: NOT-NS-20-095 Key Dates Release Date: August 5, 20 First Available Due Date: October 14, 2020 Expiration Date: July 15, 2021 Related Announcements PAR-20-285 - NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention UG3/UH3 Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS issuing Notice Special Interest applications establish master protocol conduct platform trials treatments ischemic stroke due large vessel occlusion. Master protocols should incorporate advanced clinical trial methodologies such as, not limited to, Bayesian modeling, response adaptive randomization, shared controls, the ability treatment arms enter, leave, be combined. Master protocols must designed allow future addition trial questions. Strong representation expertise the neurology, neurosurgery, interventional communities required such multi-disciplinary approach will expected applicants. Research Objectives Recent pivotal interventional trials patients ischemic stroke due large vessel occlusion shown mechanical thrombectomy be highly beneficial certain groups patients to 24 hours after last known well. However, questions remain the potential benefit harm thrombectomy specific subgroups patients certain ischemic stroke phenotypes. Also interest considerations such pre-hospital care peri-procedural management strategies. Further, success mechanical thrombectomy raises possibility a new era neuroprotection patients large vessel ischemic stroke. Promising neuroprotectants failed trials predated successful reperfusion, well newer agents have potential remain untested, ripe consideration this new environment. NINDS interested master protocols enable platform trials answer above questions using seamless rolling approach. Trials further refine patient groups do do benefit mechanical thrombectomy, using management approaches, also open door testing neuroprotectant strategies an efficient, timely, cost-effective manner. Clinical study protocols consist acute short-term procedures are deemed Non-Significant Risk NSR) an Institutional Review Board IRB), Significant Risk SR) studies require Investigational Device Exemption IDE) the FDA. Evidence contact appropriate U.S. regulatory bodies e.g., IRB NSR studies and/or FDA the form either Pre-Submission meeting IDE submission SR studies recommended. Applicants must the resources ability do work without critically impacting high-priority, on-going NINDS research programs. Investigators planning submit application response the NOSI strongly encouraged contact program officer listed below discuss proposed project. Application Submission Information notice applies due dates or after October 14, 2020 subsequent receipt dates through July 14, 2021.  Applications this initiative must submitted using following funding opportunity announcement FOA) any reissues these announcement through expiration date this notice: PAR-20-285 - NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention UG3/UH3 Clinical Trial Optional) instructions the SF424 R&R) Application Guide the funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include “NOT-NS-20-095” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications non-responsive terms this NOSI be be considered the NOSI initiative. Applications nonresponsive terms this NOSI will not considered the NOSI initiative. Inquiries Please direct inquiries the Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.